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OpenTrials
Suspended

NCT Number: NCT04017819

Biodistribution & Pharmacokinetic of Position Emission Tomography (PET) Radiopharmaceutical 18F C SNAT4

Primary Objectives

* Determine the biodistribution of [18F]-C-SNAT4 in 5 healthy volunteers. Secondary Objectives * Determine the dosimetry of [18F]-C-SNAT4 PET in healthy volunteers and patients with lung cancer. * Determine the acute toxicity of [18F]-C-SNAT4 PET in healthy volunteers and patients with lung cancer. * Determine whether uptake in [18F]-C-SNAT4 PET imaging is significantly different in tumor and corresponding contralateral noncancer tissue in patients with lung cancer (tested by Wilcoxon test) before the therapy. * Determine/verify the safety profile of the [18F]-C-SNAT4 radiotracer, as an imaging agent in patients with lung cancer. * Determine the time of maximal [18F]-C-SNAT4 radiotracer uptake post injection.

Why the study stopped: funding
Suspended

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Stanford University

Stanford, California, 94304, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ANC ≥ 1.5 x 109/L without myeloid growth factor support for 7 days preceding lab assessment
  • Hgb ≥ 9 g/dL (90 g/L); < 9 g/dL (< 90 g/L) is acceptable if Hgb corrected to ≥ 9 g/dL (90 g/L) as by growth factor or transfusion prior to PET scan
  • Platelet count ≥ 100 x 109/L w/o blood transfusions for 7 days preceding lab assessment
  • Bilirubin ≤ 1.5 x upper limit of normal (ULN) except for pts with documented history of Gilbert's disease
  • ALT ≤ 2.5 x ULN
  • AST ≤ 2.5 x ULN
  • Alkaline phosphatase (AP) ≤ 3 x ULN
  • If a women of childbearing potential (WCBP): negative early pregnancy test (EPT)
  • Karnofsky Performance Status (KPS) ≥ 60
  • Ability to understand and the willingness to sign a written informed consent document

Exclusion criteria

  • Has already begun non-surgical therapy for any recurrence, prior to the first [18F]-C-SNAT4 PET/CT scan
  • Severe/uncontrolled inter-current illness within the previous 28 days prior to PET scan.
  • Any other significant co-morbid conditions that in the opinion of the Investigator would impair study participation or cooperation.
  • History of allergic reactions to IV contrasts or reactions attributed to compounds of similar chemical or biological composition to [18F]-C-SNAT4 used in study.
  • Pregnant or nursing
  • Patients who exceed the safe weight limit of the PET/CT bed (204.5 kg) or who cannot fit through the PET/CT bore (diameter 70 cm).

Treatment and study plan

18F-C-SNAT4

Drug

Radiotracer- Dose 10 mCi

Positron emission tomography (PET)/Computed tomography (CT) Scan

Device

Positron emission tomography (PET)/Computed tomography (CT) Scan

Primary outcomes

  1. Biodistribution of [18F]-C-SNAT4

    Time frame: 1 day

    Whole-body [18F]-C-SNAT4 PET scans will be performed at 60 min post intravenous injection of the PET tracer in Group 1 of 5 healthy volunteers

Secondary outcomes

  1. Dosimetry of [18F]-C-SNAT4

    Time frame: 1 day

    Radiation dosimetry of the [18F]-C-SNAT4 radiotracer will be measured through careful monitoring of each participant's vital signs in Group 1 and group 2. Time-Activity curves will be graphed by measuring activity in various organs using multiple PET/CT scans (1 hour dynamic scan, 1 hour and 2 hours) after tracer injection. Absorbed radiation will be calculated.

  2. Toxicity of [18F]-C-SNAT4

    Time frame: 7 days

    The acute [18F]-C-SNAT4 toxicity will be assessed as related adverse events, including laboratory abnormalities, that occur within 7 days of the infusion of [18F]-C-SNAT4.

  3. 18F]-C-SNAT4 Uptake

    Time frame: 1 day

    The tumor uptake of [18F]-C-SNAT4 PET will be compared with the corresponding contralateral non-cancer tissue in patients with lung cancer before the therapy in Group 2 and 3. SUVmax measurements will be taken from the pre-treatment scan.

  4. The Maximal [18F]-C-SNAT4 Uptake as PET Radiotracer

    Time frame: 1 day

    The time of maximal [18F]-C-SNAT4 radiotracer uptake post-injection will be assessed in Group 2 and 3. Time-Activity Curves (TAC) will be graphed by measuring activity in tumor after tracer injection. The maximal of [18F]-C-SNAT4 radiotracer uptake post-injection in lung cancer patients will be determined from these time activity curves.

  5. [18F]-C-SNAT4 PET Imaging Signal in Responders and Non-responders

    Time frame: 7 days

    The [18F]-C-SNAT4 PET scan signal from pre-therapy to one week after initiation of therapy in Group 3 will be compared both in treatment responders vs. non-responders. SUVmax will be measured in both the pre-treatment and one-week post-initiation of treatment scans.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

Biodistribution and Pharmacokinetic Study of the Positron Emission Tomography (PET) Radiopharmaceutical [18F]-C-SNAT4

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 12, 2019
Registry last updated
Aug 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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